medical affairs and scientific communications forum · track 1: medical communications track 2:...

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| OverviewThe Medical Affairs and Scientific Communications Forum is a cross-functional forum for knowledge sharing and integrated thought leadership, for the purposes of gaining further expertise and networking opportunities in a specific area of work, as well as related functional areas. The sessions are developed to meet the needs of those who work in pharmaceutical-based medical affairs and scientific communications.

| Highlights• Full-day Primer course on March 18 to prepare you for the full Forum

• Three Preconference Short Courses to expand your learning opportunities

• Four breakout sessions within three educational tracks covering medical communications, medical writing, and medial science liaisons

• Multiple networking opportunities with your peers, speakers, and exhibitors

• NEW! DIAfit yoga classes on Tuesday and Wednesday morning to start your morning off on the right foot

• Podium Pearls Presentations on best practices

• Two poster sessions highlighting original research from fellows, residents in training, and professionals

• Exhibit Hall with 30+ exhibiting companies

| Who Should Attend?Professionals involved in:

• Medical Communications

• Medical Writing

• Medical Liaisons

• Medical Information

• Medical Call Center Environment

• Regulatory Affairs

• Clinical Research

• Professional Education, Training and Development

• Document Management/eSubmissions

David Bowers, PharmD Director, Medical Communications PPD

Poonam Bordoloi, PharmD I&I Lead: Research and Early Pipeline Medical Communications Celgene Corporation

Darryl Zachary L’Heureux, PhD, MPharm, MSc Medical Writing Manager Bristol-Myers Squibb

Eileen Girten, MS Principal Medical Writer PRA Health Sciences

J. Lynn Bass, PharmD Director, Medical Science Liaisons (Americas) PRA Health Sciences

Robin Winter-Sperry, MD Head, Global Field Based Medical Excellence & Insights Sanofi Genzyme

PROGRAM CO-CHAIRS

Medical Affairs and Scientific Communications ForumPrimer: March 18 | Short Courses: March 19 | Forum: March 19-21 Omni Ranchos Las Palmas Resort and Spa | Rancho Mirage, CA

Kevin Appareti, MBA Senior Director, Global Medical Science Liaison Philips HealthTech

Anne Arvizu, PharmD, FASCP, PCC CEO and Medical Affairs Advisor RxER Communications

Peter Baumeister, PhD Senior Manager, Global Scientific Communications Amgen, Inc.

Kathryn Bucci, PharmD Senior Director, Medical Governance Lead Pfizer, Inc

Stephanie Byrdé, BSN, MS, RN Manager, Clinical Pharmacology Scientific Communications Eli Lilly and Company

Ivy Lee Chang, PharmD Associate Director, Medical Communications Genentech, Inc., A Member of the Roche Group

Michael Church, MA Senior Director, Medical Writing Syneos Health

Ed Cunningham, PharmD Senior Director, Neurology Medical Science Liaison Lead Sunovion Pharmaceuticals, Inc

Rebecca Falcone, PharmD Senior Manager, US Medical Information Services Sanofi

Maureen Feeney, PharmD, MBA, RPh Head Global Medical Information Shire Pharmaceuticals

Kathleen Guindon, PhD, MS, RN Director, Clinical Science Liaison Puma Biotechnology

Jennie Jacobson, PhD Lead Medical Writer Fishawack Communications

Craig Klinger, RPh Consultant, Field Medical Liaison Strategy and Capabilities - Trainer Eli Lilly and Company

Christi Marsh, PharmD Director, Medical Affairs, Medical Information and Scientific Communication HEMA Biologics, LLC

Jeff Mathews, MPH Director, Medical Information Gilead Sciences

David Meats Global Scientific and Regulatory Documentation Syneos Health

David Price, PhD Consultant – Office of Medical Professional Development (MSL Trainer) Eli Lilly and Company

Rebecca Vermeulen, RPh Head, Customer Strategy Global Medical Affairs Hoffmann-La Roche Ltd., Switzerland

Robin Whitsell President Whitsell Innovations, Inc.

Jim Wilkinson, PhD Executive Director, Global Medical Affairs Amgen, Inc.

Ann Winter-Vann, PhD Senior Medical Writer and Consultant Whitsell Innovations, Inc.

PROGRAM COMMITTEE

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| Featured TracksMedical Communications Track

Hear from industry experts on the latest approaches in medical communication, from the creation of patient-centric medical information deliverables to managing digital channels. The program is designed for medical information and communication professionals by medical information and communication professionals. This is your opportunity to gain insight into the latest challenges and opportunities impacting med info/com professionals!

Medical Writing Track This is the forum to network and learn from colleagues in and supporting Medical Writing. Industry experts will share the latest approaches in medical regulatory and publication writing. Topics discussed this year include health economics outcomes research publication considerations, clinical data disclosure requirements for submission, and implementation of common protocol templates.

Medical Science Liaison TrackMedical Science Liaisons will find a comprehensive and cohesive agenda curated and peer-reviewed by recognized thought leaders in the MSL community. The high-quality, non-biased content is developed by MSLs for MSLs in DIA’s global neutral forum. This is your opportunity to interact with – and be – an MSL thought leader.

SAVE THE DATE!Medical Affairs and Scientific

Communications ForumMarch 17-20, 2019

Loews Sapphire Falls Resort Orlando, FL

Learn More at DIAglobal.org/MASC19

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| Dear Colleagues,

We are pleased to welcome you to DIA’s Medical Affairs and Scientific Communications Forum!

This forum is unique in setting the stage for an open, collaborative discussion of important topics and tools for medical scientific communications professionals to navigate the dynamic and quickly changing healthcare environment. Experts across the three central tracks, Medical Writing, Medical Communications, and Medical Science Liaisons, will be presenting. We are truly three meetings in one, with plenaries planned to create a cross-functional experience for knowledge sharing, integrated thought leadership, and proactive networking.

We will kick off with a full day Primer on Sunday and three half day Short Courses on Monday morning (note these courses require an additional fee). The main forum will begin in the afternoon on Monday and will feature our first keynote address by Paul Grant. We will lead into our first round of breakout sessions and end the day with an amazing welcome reception to be held outside on the roof terrace.

Tuesday we start the day with our second keynote address by Pam Cyrus, MD, Vice President and Head of Medical Governance, Pharmaceuticals, at Bayer!

We hope you will take advantage of the many opportunities to actively engage in discussions and with each other. Be sure to join us Tuesday evening for the Residents and Fellows Poster Session/Networking Reception followed by a Dinner on the Town. Wednesday don’t miss the luncheon featuring professional posters and our closing professional development session!

Best Regards,

The 2018 Medical Affairs and Scientific Communications Forum Program Committee





| Schedule At-A-GlanceTrack 1: Medical Communications Track 2: Medical Writing Track 3: Medical Science Liaisons

PRIMER COURSE | SUNDAY, MARCH 18 ROOM

8:00AM-5:00PM Medical Communications Primer Registration *This course requires an additional registration fee

Ballroom Foyer

8:30AM-5:00PM Medical Communications Primer: The Fundamentals of Medical Communications Salon ABC

DAY ONE | MONDAY, MARCH 19 ROOM

8:00-9:00AM Short Course Registration *Courses require an additional registration fee

Ballroom Foyer

8:00-8:30AM Networking Breakfast for Short Course Attendees Ballroom Foyer

8:30AM-12:00PM Short Course 1: Medical Communications: Compliance in 2018Short Course 2: Advertising, Promotion, and Scientific Content Review ProcessShort Course 3: Wearing Multiple Hats with Style: How to Effectively Manage Your Medical Writing Projects

Salon FGSalon A Salon C

10:00AM-12:00PM MSL Community Round Table Salon H

11:00AM-5:05PM Forum Registration Ballroom Foyer

12:40-1:00PM DIA Mobile App Tutorial Salon DE

1:00-1:30PM Welcoming Remarks Salon DE

1:30-2:30PM Session 1: Keynote Address: Future Capability and the World of Tomorrow Salon DE

2:30-3:00PM Refreshment and Networking Break in the Exhibit Hall Fiesta Ballroom

3:00-4:00PM Session 2: Breakout Sessions

Track 1: I Don’t Need a Trophy, Grandpa! Rethinking the Myths of the Generation GapsTrack 2A: Medical Writing: Are You Calling Me Transparent? Insights into Clinical Trial Transparency: Layperson Summaries and the Plain Language InitiativeTrack 2B: The International Committee of Medical Journal Editors’ Authorship and Data Sharing Statement Requirements: What and WhyTrack 3: Seeking Optimization of the MSL Role in an Industry of Disruptive Forces

Salon ESalon D

Salon ABC

Salon FG


Track 1/3: It Takes a Village: Collaboration for One Medical VoiceTrack 2A: The Trouble with IgG: Immunogenicity in the Clinical Development of BiologicsTrack 2B: Improving the Reporting of Clinical Trials

Salon ESalon DSalon ABC

5:05-6:30PM Networking Reception Starlight Terrace

DAY TWO | TUESDAY, MARCH 20 ROOM

6:00-7:00AM DIAfit: Good Morning Sunrise Stretch with Light Yoga Salon H

7:00AM-5:30PM Registration Ballroom Foyer

7:00-8:00AM Networking Breakfast in the Exhibit Hall Fiesta Ballroom

8:00-9:00AM Session 4: Keynote Address: Medical Affairs: Where Are We today and Where Will We be in the Future?

Salon DE

9:00-9:30AM Session 5: DIA Communities Update Salon DE

9:30-10:00AM Refreshment and Networking Break in the Exhibit Hall Fiesta Ballroom

10:00-11:00AM Session 6: Breakout Sessions

Track 1: Strategic Deployment of MI “Troops” and Capitalizing on New Technologies for MI CollaborationsTrack 2: Alpha and Alphabet: Statisticians and Medical Writers Working TogetherTrack 3: Fishing for Insights and Extending the Engagement Beyond the Congress

Salon E

Salon DSalon F





DAY TWO | TUESDAY, MARCH 20 ROOM

11:05AM-12:35PM Session 7: Breakout Sessions

Track 1A: One Medical Voice: Ensuring Consistent, Quality Medical Information Responses GloballyTrack 1B: The Art and Science of Medical Information Contact Center StaffingTrack 2: Contemplate Your Template: New or Used Options for Protocol DevelopmentTrack 3: Policy Updates: The Evolution of Customer-Facing Medical Roles

Salon E Salon DSalon ABCSalon FG

12:35-2:00PM Networking Luncheon in the Exhibit Hall Fiesta Ballroom

12:35-2:00PM Fellow and Resident Professional Development Session: Personality Types and Leadership Characteristics

Salon H


Track 1: Gold! Gold! Gold from Medical Information!Track 2A: Interstellar: Crossing the Galaxy Between Pharma and Medical Devices/Companion DiagnosticsTrack 2B: Brave New World: Planning for Global Submissions in a Post-Disclosure WorldTrack 3: Best Practices for Capturing Key Performance Indicators (KPIs) and Metrics for MSLs

Salon ESalon D

Salon ABCSalon FG

3:30-4:00PM Refreshment and Networking Break in the Exhibit Hall Fiesta Ballroom


Track 1: Mixology: Headaches and Cures for Medical Information ChallengesTrack 2A: Scientific Communication StrategyTrack 2B: Secrets of the Editorial OfficeTrack 3: Are You Prepared to Ride the Tsunami of Change in Medicine or Will You Drown?

Ballroom FoyerSalon DSalon ABCSalon FG

5:30-6:30PM Resident and Fellow Poster Reception and Networking Fiesta Ballroom

7:00PM Dinner on the Town

DAY THREE | WEDNESDAY, MARCH 21 ROOM

6:00-7:00AM DIAfit: PIYO Mix (Pilates/Yoga) Salon H

7:00AM-2:30PM Registration Ballroom Foyer

7:00-8:00AM Networking Breakfast in the Exhibit Hall Fiesta Ballroom

8:00-9:30AM Session 10: Breakout Sessions

Track 1: Podium PearlsTrack 2: Managing Up, Down, and Across: Effective Medical Writing Management Strategies and Business PracticesTrack 3: The Strategic MSL – Applying Business Acumen

Salon ESalon D

Salon FG

9:30-10:30AM Refreshment and Networking Break in the Exhibit Hall - View Professional Posters! Fiesta Ballroom

10:30AM-12:00PM Session 11: Breakout Sessions

Track 1: Global Warming: Conserve Energy and Unify PartnersTrack 2A: Understanding Patient-Reported Outcomes (PROs) in Clinical Trials: The Value of Patient Experience Track 2B: Personalized Medicine: Gene TherapyTrack 3: MSL Training – All Things Considered

Salon ESalon D

Salon ABCSalon FG

12:00-1:30PM Networking Luncheon in the Exhibit Hall - View Professional Posters! Fiesta Ballroom

1:30-2:45PM To Thine Own Self be True: How Understanding Who You Are and What You Want Will Help You Build and Market Your Brand

Salon E

1:30-3:30PM Career Fair Ballroom Foyer

3:30PM Conference Adjourns

| Schedule At-A-GlanceTrack 1: Medical Communications Track 2: Medical Writing Track 3: Medical Science Liaisons





DIA is accredited by the Accreditation Council for Pharmacy Education as

a provider of continuing pharmacy education. This program is designated

for up to 20.75 contact hours or 2.075 continuing education units (CEU’s).

DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs

through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My

Transcript within 45-days post activity. If ACPE credit is not requested by Sunday, May 6, 2018, the CEU request will not

be transmitted through to the CPE Monitor. Pharmacists will need to provide their National Association of Boards of

Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly.

As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET

Standard. DIA is authorized by IACET to offer up to 2.3 CEUs for this program. Participants must attend

the entire forum (primer and/or short courses if applicable) in order to be able to receive an IACET

statement of credit. No partial credit will be awarded.

If you would like to receive a statement of credit, you must attend the forum (primer and/or short courses if applicable),

complete the “Verification of Attendance” form located in your forum folder, turn in your form to the registration desk at

the conclusion of the forum, and complete the online credit request process through My Transcript. Participants will be

able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for

credit requests on Wednesday, April 4, 2018.

| Continuing Education

ACPE CREDIT REQUESTS MUST BE SUBMITTED BY SUNDAY, MAY 6, 2018

ACCESS PRESENTATIONS

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TO ACCESS MY TRANSCRIPT

• Visit DIAglobal.org, select “Sign in” and you will be prompted for your user ID and password

• Choose MENU, found in the upper left corner

• Under CONFERENCES select “Continuing Education”

• Select the blue “My Transcript” button followed by “Credit Request” to process your credit request for the course





Medical Communications Primer: The Fundamentals of Medical Communications

Pharmacy 7 contact hours or .7 CEUs, UAN: 0286-0000-18-017-L04-P; IACET .7 CEUs

Short Courses

Short Course 1: Medical Communications: Compliance in 2018: Pharmacy 3.25 contact hours or .325 CEUs, UAN: 0286-0000-18-018-L04-P; IACET .3 CEUs

Short Course 2: Advertising, Promotion, and Scientific Content Review Process: Pharmacy 3.25 contact hours or .325 CEUs, UAN: 0286-0000-18-019-L04-P; IACET .3 CEUs

Short Course 3: Wearing Multiple Hats with Style: How to Effectively Manage Your Medical Writing Projects: IACET .3 CEUs

Forum Pharmacy Credit Breakdown

Session 2 Track 1: I Don’t Need a Trophy, Grandpa! Rethinking the Myths of the Generation Gaps: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-020-L04-P

Session 2 Track 2A: Medical Writing: Are You Calling Me Transparent? Insights into Clinical Trial Transparency: Layperson Summaries and the Plain Language Initiative: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-021-L04-P

Session 2 Track 3: Seeking Optimization of the MSL Role in an Industry of Disruptive Forces: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-022-L04-P

Session 3 Track 1/3: It Takes a Village: Collaboration for One Medical Voice: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-023-L04-P

Session 3 Track 2A: The Trouble with IgG: Immunogenicity in the Clinical Development of Biologics: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-024-L04-P

Session 3 Track 2B: Improving the Reporting of Clinical Trials: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-025-L04-P

Session 6 Track 1: Strategic Deployment of MI “Troops” and Capitalizing on New Technologies for MI Collaborations: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-026-L04-P

Session 6 Track 2: Alpha and Alphabet: Statisticians and Medical Writers Working Together: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-027-L04-P

Session 6 Track 3: Fishing for Insights and Extending the Engagement Beyond the Congress: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-18-028-L04-P

Session 7 Track 1A: One Medical Voice: Ensuring Consistent, Quality Medical Information Responses Globally: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-029-L04-P

Session 7 Track 1B: The Art and Science of Medical Information Contact Center Staffing: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-030-L04-P

Session 7 Track 2: Contemplate Your Template: New or Used Options for Protocol Development: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-031-L04-P

Session 7 Track 3: Policy Updates: The Evolution of Customer-Facing Medical Roles: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-032-L04-P

Session 8 Track 1: Gold! Gold! Gold from Medical Information!: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-033-L04-P

Session 8 Track 2A: Interstellar: Crossing the Galaxy Between Pharma and Medical Devices/Companion Diagnostics: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-034-L04-P; IACET .15 CEUs

Session 8 Track 2B: Brave New World: Planning for Global Submissions in a Post-Disclosure World: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-035-L04-P

Session 8 Track 3: Best Practices for Capturing Key Performance Indicators (KPIs) and Metrics for MSLs: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-036-L04-P

Session 9 Track 1: Mixology: Headaches and Hangover Cures: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-037-L04-P

Session 9 Track 2A: Scientific Communication Strategy: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-038-L04-P

Session 9 Track 3: Are You Prepared to Ride the Tsunami of Change in Medicine or Will You Drown?: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-039-L04-P

Session 10 Track 1: Podium Pearls: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-040-L04-P

Session 10 Track 3: The Strategic MSL – Applying Business Acumen: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-041-L04-P

Session 11 Track 1: Global Warming: Conserve Energy and Unify Partners: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-042-L04-P

Session 11 Track 2A: Understanding Patient-Reported Outcomes (PROs) in Clinical Trials: The Value of Patient Experience: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-043-L04-P

Session 11 Track 2B: Personalized Medicine: Gene Therapy: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-044-L04-P

Session 11 Track 3: MSL Training – All Things Considered: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-18-045-L04-P

Sessions not available for Pharmacy Credit: Short Course 3, Community Round Table, DIA Mobile App Tutorial, Welcoming Remarks, Session 1, Session 2 Track 2B, Session 4, Session 5, Fellow and Resident Professional Development Session, Session 9 Track 2B, Poster Reception, Session 10 Track 2, To Thine Own Self be True

| Continuing Education Allocation





PRIMER | SUNDAY, MARCH 18

8:00AM-5:00PM Medical Communications Primer Registration8:30AM-5:00PM*This course requires an additional registration fee*

Medical Communications Primer: The Fundamentals of Medical CommunicationsLead InstructorKristin Goettner, PharmD Director, Medical Information Janssen Scientific Affairs, LLC

Co-Instructors

Shelby Biagi, PharmD Scientific Engagement and Communication Lead UCB, Inc.

Jackie Byun, PharmDManager, Medical Information Services Sanofi

Payal Desai, PharmD Associate Director, Medical Information Janssen Scientific Affairs, LLC

Sabrina Lo, PharmD Senior Scientist, Managed Care Medical Communications Genentech, a Member of the Roche Group

Margaret May, MLS, AHIPLiterature Research Analyst, US Medical Affairs Genentech, a Member of the Roche Group

Ankur Shah, PharmD Director, US Medical Information Incyte Corporation

Ellen Whipple, Pharm, PharmDDirector, Medical Communications Med Communications, Inc.

Healthcare professionals and patients look to medical communication and medical information professionals to provide essential, accurate, and unbiased drug information, therefore making medical communications an integral part of the healthcare industry. Because we work in the second most regulated industry, the pharmacy professionals who provide these services need to have a comprehensive understanding of not only the medical content, but also the regulatory and compliance environment which directly affects their daily activities.

This workshop will address many of the common responsibilities of medical communications staff and dig deeper into challenging aspects of each role. This activity is specifically designed to meet the needs of individuals new to biopharmaceutical industry-based medical communications. Many times, their understanding is limited to only their own company’s SOPs and “way of doing things.” In this activity, you will learn and discuss important skill sets that provide value to both internal and external customers and compare these across companies. These include activities such as identifying the critical steps that a medical communications professional should take when receiving an inquiry, evaluating the sources of information/data, and the importance of fair balance and documenting responses. Topics will also include important elements of writing a standard response letter (formulary dossier communications), promotional review committee best practices, and activities at scientific congresses. Role playing and mock examples will be used to re-enforce principles that emphasize the importance of our role to the industry and to the customers we serve.

You will be presented with real-life scenarios that represent challenges that are common to our roles; groups will be asked to discuss and share their responses to the situations. You will gain a better understanding of best practices within your job function and a broader awareness of the regulatory environment. You will also learn how to work better as part of interdisciplinary teams, practice evidence-based medicine evaluation, and effectively use technology.

At the conclusion of the primer, participants should be able to:

• Describe how the regulatory environment influences medical communications practice

• Identify critical steps a medical communications professional should take when receiving an unsolicited inquiry, including evaluating the available data and sources of information

• Describe the important elements of writing a concise and clear standard response letter

• Recognize key biomedical literature resources used for answering medical information inquiries including strategies and techniques for finding literature to answer medical information questions

• Discuss medical information roles and responsibilities at medical congresses

• Recognize the differences and similarities between the roles of medical communications and medical science liaisons, including ways to share information and resources and share best practices and ideas for collaboration to enhance productivity and value for both organizations

• Discuss ways that medical communications professionals can support the needs of managed care customers including understanding the background, content, and purpose of the AMCP Formulary Dossier

• Describe the distinct scientific value that medical communications provides on promotional review committees





DAY ONE | MONDAY, MARCH 198:00-9:00AM Short Course Registration8:00-8:30AM Networking Breakfast for Short Course Attendees8:30AM-12:00PM*Short Courses require an additional registration fee*

Short Course 1Medical Communications: Compliance in 2018Co-InstructorsMonica Kwarcinski, PharmD Executive Director, Medical Services Purdue Pharma L.P.

The compliance obligations within the pharmaceutical industry continue to increase each year. Now more than ever it is critical that medical communication departments have policies and procedures that address such things as medical inquiry and response documentation, staff training, and monitoring/audit programs. Whether you have been in medical communications for a few months or a few decades, this short course will provide an overview of what policies, procedures, and programs medical communications departments should consider implementing to help ensure compliance and mitigate risk. This will be an interactive course with opportunity for discussion and questions.

At the conclusion of the short course, participants should be able to:

• Discuss compliance hot topics in medical communications such as medical inquiry documentation; response development, review, and dissemination; Sunshine Act reprint reporting requirements: staff training; and sales force facilitated inquiries

• Describe what policies and procedures the Office of Inspector General (OIG) is requiring medical communications departments to have in place based on recent Corporate Integrity Agreements (CIA)

• Identify the factors to consider when developing, implementing, and maintaining QA, compliance, and training programs

• Describe how to mitigate risk in medical communication

Short Course 2Advertising, Promotion, and Scientific Content Review ProcessInstructorKristi Sanford, JD Head, US Medical Operations UCB, Inc.

This course will discuss the basics of advertising and promotion regulation (including scientific content) and then explore how to create an effective and agile system (people, process, technology, and training) to support content development, review, and management. We’ll examine how to use risk and brand maturity assessments to reduce review complexity and streamline processes for time sensitive materials.


• Review the current and evolving regulatory landscape

• Discuss how content review is a integrated system from ideation to content expiration

• Describe how each system element (training, people, process, technology) must work as a whole in an agile and continually improving structure and explore best practices for each

• Discuss how to easily incorporate risk assessments into review processes

Short Course 3Wearing Multiple Hats with Style: How to Effectively Manage Your Medical Writing ProjectsInstructorEileen Girten, MS Principal Medical Writer PRA Health Sciences

An effective medical writer needs to be skilled in negotiations, collaborations, time management, team building, setting goals, interpersonal skills, and accepting criticism. However, such skills may be overlooked at the expense of focusing on the document types and therapeutic areas. Therefore, it is important to consider and develop such skills to help produce quality deliverables on time and cultivate client-customer relationships. This workshop will incorporate the DIA Medical Writing Competency model and include breakout sessions to brainstorm and discuss approaches to the writing project lifecycle. This workshop is appropriate for medical writers or other individuals who wish to further develop their project management skills.


• Summarize why project management skills are important for medical communicators

• Identify resources and skills that are helpful for delivering projects for all stakeholders involved

• Examine best practices for managing tasks throughout the project’s lifecycle

• Apply techniques for successfully launching, managing, and completing projects

Mark DeWyngaert, PhD Managing Director, Life Sciences Deloitte & Touche, LLP





DAY ONE | MONDAY, MARCH 19

11:00AM-5:05PM Forum Registration12:40-1:00PM DIA Mobile App Tutorial1:00-1:30PM Welcoming Remarks

Sudip Parikh, PhD Senior Vice President and Manageing Director, Americas DIA

Medical Writing Track Co-Chair Eileen Girten, MS Principal Medical Writer PRA Health Sciences

Medical Science Liaisons Track Co-Chair Robin Winter-Sperry, MD Head, Global Field Based Medical Excellence & Insights Sanofi Genzyme

Medical Communications Track Co-Chair David Bowers, PharmD Director, Professional Contact Center PPD

1:30-2:30PM Session 1Keynote Address: Future Capability and the World of TomorrowKeynote Speaker Paul Grant Healthcare Engagement Strategist

In the near future, continuous and rapid technological advancements will enhance and challenge our current way of working. How do we reliably plan for the capability we will need as individuals and organizations, to adapt for success in this changing world? What are the core tenets of a data-driven world that will help us flourish in future medical affairs and scientific communications?

2:30-3:00PM Refreshments and Networking Break in the Exhibit Hall3:00-4:00PM Session 2

Breakout Sessions

10:00AM-12:00PM MSL Community Round Table Are you seeking an opportunity to connect with Medical Science Liaisons (MSLs) colleagues? This NEW addition to the agenda will provide you the opportunity to join your MSL colleagues from across the industry for interactive round table discussions with the leaders in our MSL Community. Topics to be discussed will include MSL career paths, evaluating the value of the MSL team to the organization, capturing clinical/scientific insights, and considerations for MSL on-boarding and training. This MSL Community discussion is open to everyone interested in learning and sharing best practices regarding the MSL role.

TRACK 1

I Don’t Need a Trophy, Grandpa! Rethinking the Myths of the Generation

Gaps

TRACK 2A

Medical Writing: Are You Calling Me Transparent? Insights into Clinical Trial

Transparency: Layperson Summaries and the Plain Language Initiative

TRACK 2B

The International Committee of Medical Journal Editors’ Authorship and Data

Sharing Statement Requirements: What and Why

TRACK 3

Seeking Optimization of the MSL Role in an Industry of Disruptive Forces

Session Chair Peter Baumeister, PhD Senior Manager, Global Scientific Communications Amgen, Inc.

Gain an overview of the generational differences present in the workplace and how each one is perceived and compare it to empirical evidence. This session will also cover what really motivates each generation in the workplace and present a model for how to bridge the gaps. You will have an opportunity to participate and have fun with this often-discussed topic.

At the conclusion of this session, participants should be able to:• Define the generations present in the

current workplace

• Identify the formative events and challenges associated with each generation

• Evaluate the numbers and predictions for each generation

• Recognize the factors that motivate each generation

• Develop a framework for creating and participating in a highly rewarding, trans-generational work environment

Peter Baumeister, PhD Senior Manager, Global Scientific Communications Amgen, Inc.

Amber Daughtery, MBA Senior Training Manager, Global Learning and Performance – R&D Amgen, Inc.

Session Chair David Meats Global Scientific and Regulatory Documentation Syneos Health

Discuss the continuously expanding approach to transparency in pharmaceutical development. We will discuss the most current breaking developments in the Clinical Trial Transparency space. In addition, we will cover tips for the development of trial summaries using plain language and what patients and health care providers want from these summaries.

At the conclusion of this session, participants should be able to:• Understand what returning results of

clinical trials means to patients and health care providers

• Discuss the current regulation requirements of clinical trial summaries

• Describe the real-world MRCT experiences for the creation and maintenance of clinical trial summaries and returning results to patients and public

• Describe the evolution of patient and public power as stakeholders, and the need to gain the public’s trust

• Understand what the future challenges are, and how plan language summaries should be made available

Deborah Collyar President Patient Advocates In Research (PAIR)

Theresa Shalaby, MSN, RN, CCRP Senior Regulatory Writer Synchrogenix; A Certara Company

Session Chair Eileen Girten, MS Principal Medical Writer PRA Health Sciences

Thousands of medical journals indicate that they follow the ICMJE’s recommendations for the conduct, reporting, editing, and publication of scholarly work in Medical Journals. These include criteria for authorship as well as newly announced requirements for the inclusion of data-sharing statements in manuscripts describing the results of clinical trials. This session will analyze the rationale for these requirements and how to meet them.

At the conclusion of this session, participants should be able to:• Describe the ICMJE requirements for

manuscript authorship and for data-sharing statements

• Explain the reasons why these requirements have been adopted

• Apply authorship and data sharing statement requirements to plan studies and publications

Darren Taichman Executive Deputy Editor Annals of Internal Medicine

Session Chair J. Lynn Bass, PharmD Director, Medical Science Liaisons, Americas Santen, Inc.

This session will peek into the variety of technological advances and scientific innovation to review how these contribute to the positive disruption currently underway in the MSL role.

At the conclusion of this session, participants should be able to:• Review the benefits and risks of

disruptive forces within the current pharmaceutical environment

• Summarize meaningful examples of how these disruptive forces are impacting the MSL role

• Detect how the future of the MSL role will be positively affected

J. Lynn Bass, PharmD Director, Medical Science Liaisons, Americas Santen, Inc.

Lori Mouser, PharmD Global head, Medical Science Liaison F. Hoffmann-La Roche, Ltd.





DAY ONE | MONDAY, MARCH 194:05-5:05PM Session 3

Breakout SessionsTRACK 1/3

It Takes a Village: Collaboration for One Medical Voice

TRACK 2A

The Trouble with IgG: Immunogenicity in the Clinical Development of Biologics

TRACK 2B

Improving the Reporting of Clinical Trials

Session Co-Chairs Rebecca Falcone, PharmD Senior Manager, US Medical Information Services Sanofi

Jim Wilkinson, PhD Executive Director, Global Medical Affairs Amgen, Inc.

This session will highlight the value that collaboration can bring between Medical Information, Field Medical (MSLs), Health Outcomes, and Scientific Communications to provide one medical voice. The importance of collaborations between internal stakeholders to align on external engagements and deliverables will be discussed.

At the conclusion of this session, participants should be able to:

• Explain the necessary collaborations between HEOR and Medical Affairs to provide a value story for Payers

• Describe the value of a highly-collaborative global team including MSLs, Medical Information, and Scientific Communications for the creation of MSL strategy, tactical plans, training plans, and medical resources

• Identify best practices for creating a collaborative team

Donna Booth, PharmD Director, Medical Information, Neurology and Psychiatry GlaxoSmithKline

Jennifer Slade, PharmD Senior Director, Global Lead MSLs Novartis Pharmaceuticals

Session Chair Darryl L’Heureux, MsC, PhD, Mpharm Medical Writing Manager Bristol-Myers Squibb

While proteins have a dynamic role in the body (catalyzing biochemical reactions, forming receptors and channels in membranes, providing intracellular/extracellular scaffolding, and transporting molecules), protein-based therapeutics have a tendency to trigger unwanted immune responses against themselves. This session will discuss immunogenicity, the safety and efficacy implications in clinical development, and the communication of risk to stakeholders.


• Identify the use of therapeutic proteins in treatment, immunogenicity response, and regulatory requirements

• Assess risk-based approaches for clinical development and communication to Health Authorities

• Communicate clinical relevance and significance of immunogenicity to both patients and clinicians

Darryl L’Heureux, MsC, PhD, Mpharm Medical Writing Manager Bristol-Myers Squibb

Lisa Iacono Sheehan, PharmD Principal Documentation Lead Bristol-Myers Squibb

Session Chair Jennie Jacobson, PhD Lead Medical Writer Fishawack Communications

Clinical trial data presentation in the medical literature is under increasing scrutiny. It must be accurate, balanced, and comprehensive, but also concise. Publications must adhere to a variety of guidelines, including the ICMJE recommendations and GPP3. The panel will lead a group discussion of challenges and solutions for improving reporting of clinical trials.


• Assemble authoring teams to improve presentation of clinical trial data by using the ICMJE recommendations and GPP3

• Assess effectiveness of data quality reviews

• Implement best practices shared by the panel and by audience members

Darren Taichman, MD, PhD Executive Deputy Editor Annals of Internal Medicine

David Clemow, PhD Advisor Scientific Communications Strategy, Neuroscience Eli Lilly and Company

Jennie Jacobson, PhD Lead Medical Writer Fishawack Communications

5:05-6:30PM Networking Reception

6:00-7:00AM DIAfit: Good Morning Sunrise Stretch with Light YogaInstructor Tracy Meats Certified Personal TrainerStart your day with a rejuvenating class to stretch the body and practice mindful breathing.

7:00AM-5:30PM Registration7:00-8:00AM Networking Breakfast in the Exhibit Hall8:00-9:00AM Session 4

Keynote Address: Medical Affairs: Where Are We Today and Where Will We be in the Future?Pam Cyrus, MD Vice President and Head of Medical Governance, Pharmaceuticals Bayer

This talk will review trends in medical affairs with a focus on pharmaceutical industry reputation, interaction with thought leaders, patient centricity and big data (real world evidence). It will also suggest the focus for the next several years.

9:00-9:30AM Session 5DIA Communities UpdateJ. Lynn Bass, PharmD Director, Medical Science Liaisons Santen, Inc.

David Clemow, PhD Advisor Scientific Communications Strategy, Neuroscience Eli Lilly and Company

Monica Kwarcinski, PharmD Executive Director, Medical Services Purdue Pharma L.P.

9:30-10:00AM Refreshments and Networking Break in the Exhibit Hall

DAY TWO | TUESDAY, MARCH 20





DAY TWO | TUESDAY, MARCH 2010:00-11:00AM Session 6

Breakout SessionsTRACK 1

Strategic Deployment of MI “Troops” and Capitalizing on New Technologies for MI

Collaborations

TRACK 2

Alpha and Alphabet: Statisticians and Medical Writers Working Together

TRACK 3

Fishing for Insights and Extending the Engagement Beyond the Congress

Session Chair Christi Marsh, PharmD Director, Medical Affairs, Medical Information and Scientific Communication HEMA Biologics, LLC

We invite you to come learn about FRESH and DIFFERENT ways two experienced medical information (MI) professionals are working in new ways. First from one member who is embedding their MI team members across functions within their organization to deliver value and “delight customers” based on insights. Second, we change gears to hear how an UBER*-like platform can be used to collaborate across drug information professionals to deliver value to customers.

*© 2017 Uber Technologies Inc. All rights reserved.


• Describe an example approach to aligning medical info teams with corporate strategy

• Demonstrate the differences between insight, observation, and reporting on data and analytics

• Identify what skills MI teams need to find insights

• Establish challenges regarding evidence-based medicine

• Discuss differences and similarities regarding the evolution of the non-industry drug information center

The Secret Sauce of Med Info: Strategic Ingredients for Your Embedding MI Teams and Insights

Michelle Clausen, PharmD Senior Director, Chief Medical Office- Strategy and Innovation Team Pfizer, Inc

How are Uber and Medical Information Related? InpharmDTM Using Technologies to Harness Medical Information Expertise Collaboratively

Ashish Advani, PharmD Clinical Associate Professor, Director of Drug Information Service Mercer University College of Pharmacy

Session Chair Stephanie Byrde, MS, BSN, RN Manager, Clinical Pharmacology Scientific Communications Eli Lilly and Company

Hear from a panel of experienced statisticians: their war stories; insights into what they value in a medical writer; the good, the bad, and the ugly about working with numbers and translating them into the written word; and what statisticians wish every medical writer understood about how to effectively work with statisticians.


• Identify key ways in which writers and statisticians can effectively partner

• Recognize and potentially eradicate misunderstandings and miscommunications between the statistics and medical writing functions

Paul Berg, MS Principal Research Scientist Eli Lilly and Company

Jenna Elder, PhD Chief Scientific Officer PharPoint Research, Inc.

Session Chair Kevin Appareti, MBA Senior Director, Global Medical Science Liaison Philips HealthTech

We will be covering the importance of uncovering insights from customers during various types of engagements at conferences and how to extend our reach beyond the confines of the forum. We will share novel ideas on how to extend the engagement with key customers so we can ensure we are connected over time to strengthen our relationships. The session will offer different perspectives from Pharma, Professional Societies, and Medical Device. There will be ample time to interact with the audience in sharing best practices and ideas on this topic.


• Identify the value of uncovering insights from our key customers

• Build strategies and tactics to extend the engagement beyond the conference venue

• Recognize different perspectives from Professional Organizations, Pharma, and Med Device on this topic

Gathering Insights and Extending Engagement with Customers - Med Device Perspective

Kevin Appareti, MBA Senior Director, Global Medical Science Liaison Philips HealthTech

Gathering Insights and Extending Engagement with Customers - DIA Perspective

Raleigh Malik, PhD Senior Scientific Liaison DIA

Gathering Insights and Extending Engagement with Customers - Pharma Perspective

J. Lynn Bass, PharmD Director, Medical Science Liaisons, Americas Santen, Inc.

Thank you to our media partners:





DAY TWO | TUESDAY, MARCH 2011:05AM-12:35PM Session 7

Breakout SessionsTRACK 1A

One Medical Voice: Ensuring Consistent, Quality Medical

Information Responses Globally

TRACK 1B

The Art and Science of Medical Information Contact Center

Staffing

TRACK 2

Contemplate Your Template: New or Used Options for Protocol Development

TRACK 3

Policy Updates: The Evolution of Customer-Facing Medical Roles

Session Chair Jeff Mathews, MPH Director, Medical Communications Gilead Sciences

Discuss ways that MI departments across three pharmaceutical companies are addressing this challenge with a comprehensive content strategy and utilizing technology to create “One Source of the Truth” for their content. The solution is only part of the story, though. This session will also uncover each company’s journey, from proof-of-concept through implementation, and discuss the best practices and lessons learned that was acquired along the way.


• Describe the importance of developing a MI content strategy and identify the resources necessary to deliver

• Explain how to manage staff and key stakeholders through change

• Cite examples on how to reuse the source of truth

• Identify and compare different technology solutions to develop and share content globally

Content is Like Water: Let it Flow

Cecil Lee, RPh Knowledge Management Advisor, Global Customer Information Eli Lilly and Company

Implementation of a Global Content Management System to Pave the Road for a Successful Global Content Strategy

Meera Patel, PharmD Associate Director, Medical Information Janssen Pharmaceuticals, Inc.

Leena Jindia, MS, PharmD Director, Medical Information Janssen Scientific Affairs

Global Content Management: A Neuroscience and Pain Story Through Word Clouds, Digital, and Non-Digital Interactions!

Rania Gaspo, PhD Director, Global Therapy Area Lead, External Medical Communications Pfizer Canada, Inc.

Session Chair David Bowers, PharmD Director, Professional Contact Center PPD

Medical Information contact centers face an array of challenging questions related to staffing, including: Should we staff with nurses, pharmacists, or other staff? How do we build a cost effective model that answers inquiries quickly and effectively with a minimal number of transfers? How do we build a flexible model that can respond to changes in volume and staffing? This will be an interactive session designed to maximize your participation and idea sharing.


• Discuss effective staffing models used in the medical information industry

• Recognize key levers that can be adjusted to impact staffing costs of a contact center

• Create strategies to increase flexibility in a contact center

Kathleen Meyer Ritz Director, Medical Capabilities, Medical Information Contact Centers Bristol-Myers Squibb

John Warwick, PharmD Director, Medical Information Grifols, Inc.

Session Chair Robin Whitsell President Whitsell Innovations, Inc.

This session will introduce the newly-issued TransCelerate Biopharma Common Protocol Template (CPT) and the NIH-FDA template. The speakers will detail the benefits and limitations of these templates, and factors for consideration when using them. In addition, we will host a case-study on creating your own protocol template, ensuring that content requirements are met, and getting endorsement from your study development team.


• Discuss the TransCelerate Biopharma Common Protocol Template (CPT) and the NIH-FDA template

• List the components (regulatory requirements and document architecture) of a well-written protocol

• Analyze the factors that influence your selection of a protocol template

TK Booker Porter, PhD Senior Manager Gobal Regulatory Writing, Protocol Authoring Lead Amgen, Inc.


Amy Holbrook, MS Director of Medical Writing Keryz Biopharmaceuticals

Session Co-Chairs Kathryn Bucci, PharmD Senior Director, Medical Governance Lead Pfizer, Inc

Ed Cunningham, PharmD Senior Director, Neurology Medical Science Liaison Lead Sunovion Pharmaceuticals, Inc.

As the demand for medical information continues to increase, this session will discuss how the interpretation and application of new FDA rules are expected to further evolve the role of customer-facing medical teams.


• Prepare an overview of recent court rulings regarding manufacturers’ ability to communicate

• Describe the current challenges in FDA rules and how they influence pharma companies

• Explain how companies are interpreting and applying the rules to customer-facing medical

• Describe what the industry can do to advance capabilities and move field-based medical roles forward

Michelle Drozd Deputy Vice President, Policy and Research Pharmaceutical Research and Manufacturers of America (PhRMA)

Michael Labson Partner Covington & Burling, LLP

12:35-2:00PM Networking Luncheon in the Exhibit Hall





12:35-2:00PM Fellow and Resident Professional Development Session: Personality Types and Leadership CharacteristicsSession Co-ChairsAlicia Cadogan Director, Oncology Medical Information Pfizer, Inc

Evelyn Hermes-DeSantis, PharmD Director, Drug Information Service, Clinical Professor, Ernest Mario School of Pharmacy Rutgers, The State University of New Jersey

In today’s workplace we find many different personality types. However, sometimes it may feel that we are expected to “fit the mold” when it comes to workplace behavior. Our actions may be driven by company values and corporate culture, leaving one to question what opportunities there are for individuality. Although it may be true that certain personality types are better fit for particular roles than others, it should not prohibit the diversity that is needed for a successful team. In this session, designed for Fellows, Residents, and their Preceptors, we will discuss a variety of personality types and challenge some preconceived thoughts of where they may best fit in our career arena. We will explore our own personality types and challenge how they align with our career a aspirations. Finally, we will discuss how leadership characteristics are not only for those who lead large groups or manage teams, but are necessary in everyone who contribute to the common goals of the organization. At the conclusion of the short course, participants should be able to:• Summarize why project management skills are important for medical communicators• Identify resources and skills that are helpful for delivering projects for all stakeholders involved• Examine best practices for managing tasks throughout the project’s lifecycle• Apply techniques for successfully launching, managing, and completing projects

2:00-3:30PM Session 8Breakout Sessions

TRACK 1

Gold! Gold! Gold from Medical Information!

TRACK 2A

Interstellar: Crossing the Galaxy Between Pharma and Medical

Devices/Companion Diagnostics

TRACK 2B

Brave New World: Planning for Global Submissions in a Post-

Disclosure World

TRACK 3

Best Practices for Capturing Key Performance Indicators (KPIs) and

Metrics for MSLs

Session Chair Ivy Chang, PharmD Associate Director, Medical Communications Genentech, Inc., A Member of the Roche Group

Sharing the metrics is easy, but what do the metrics mean without context? What are some key performance indicators that can showcase the value of MI? What are insights, how are these identified, and who should be the audience of these? During this session the faculty will share their views and experiences on demonstrating the value of medical information.


• Define insights and key performance indicators (KPIs)

• Identify insights from medical information request metrics and customer feedback

• Identify key internal stakeholders with whom to share various metrics, insights, and KPI

• Integrate value of Medical Information through customer insights and KPIs

Representative Invited Vertex Pharmaceuticals, Inc.

Joyce Fairclough, PharmD Senior Manager, Medical Information Services Sanofi

Kim Lee, PharmD Director, Multiple Myeloma Team Lead, Global Medical Information Celgene

Session Chair Robin Whitsell President Whitsell Innovations, Inc.

Gain an overview of the regulations surrounding medical devices and companion diagnostics, steps for bringing medical devices to the market, and practical knowledge in writing the associated documents. Speakers will introduce these regulations in the context of similar pharmaceutical regulations. They will detail the required documentation associated with Pre-Market Approval (PMA) and Pre-Market Notification (510(k)s) for medical devices and companion diagnostics. The speakers will also provide an overview of investigational device exemptions (IDE) and a case-study of an IDE filing.


• Compare device classifications

• Discuss regulatory documents associated with medical devices and companion diagnostics

• Organize the associated subject matter within a medical device or companion diagnostics submission

Navigating Medical Device Regulations - A Guide to the Galaxy


IVD Companion Diagnostics – A “Sirius”ly Bright Star

Cyndi Carr, PhD Senior Manager, Medical Writing Ventana Medical Systems, Inc., A Member of the Roche Group

Device Classification and Investigational Device Exemptions - Following the Laws of the Universe

Ryan Hietpas, PhD Consultant, Global Scientific Communications Eli Lilly and Company

Session Chair Robert Paarlberg, MS Principal Paarlberg & Associates, LLC

This session will be a panel discussion on hot topics in clinical trial disclosure/transparency and how they are impacting company processes and strategies as well as impact on the orphan/rare disease community. Topics to be addressed include: how disclosure requirements are impacting clinical development strategies; commercial confidential information; individual personal data; potential legal implications to patients and companies; and impact on the orphan/rare disease community.


• Identify key areas within a company impacted by the ClinicalTrials.gov Final Rule and EMA Policy 0070

• Describe how disclosure/transparency requirements are impacting approaches to protocol and clinical study report writing

• Discuss potential legal implications that disclosure is having in the US and EU

• Describe how disclosure/transparency is impacting orphan/rare disease community

Deborah Collyar President Patient Advocates in Research

Mark Barnes, JD Partner Ropes & Gray, LLP

Kelly Vaillant President Vaillant Consulting, LLC

Rebecca Williams, PharmD, MPH Assistant Director, ClinicalTrials.gov, NCBI National Library of Medicine, NIH

Session Chair David Price, PhD Field Medical Strategy and Capabilities Consultant Eli Lilly and Company

This session will start with a brief overview aimed at providing participants a basic framework on key performance indicators (KPIs) and metrics across the spectrum of Medical Science Liaison (MSL) activities and responsibilities that represent the overall value MSLs bring to customers. Topics include KPIs and metrics related to core aspects of the MSL role, product lifecycle, and MSL program size and longevity. The session will continue through a panelist-led discussion involving questions and participant responses through the DIA App. Panelists will help facilitate and guide the discussion while bridging concepts such as best practices for capturing and communicating KPIs/metrics and aligning MSL KPIs/metrics to medical affairs strategy and objectives.


• Review the variety of KPIs and metrics associated with the MSL role

• Discuss how KPIs and metrics differ based on MSL support across the product lifecycle and on the size and longevity of a MSL program

• Recognize the significance of KPIs and metrics that ladder up to medical affairs strategy

• Discuss how to collate the overall value message for MSLs that can be shared with key stakeholders

David Price, PhD Field Medical Strategy and Capabilities Consultant Eli Lilly and Company

Ed Cunningham, PharmD Senior Director, Neurology Medical Science Liaison Lead Sunovion Pharmaceuticals, Inc.

3:30-4:00PM Refreshments and Networking Break in the Exhibit Hall

DAY TWO | TUESDAY, MARCH 20

This is a session for Residents, Fellows, and their preceptors, and will be held in a separate room during the luncheon. No additional fee required.





DAY TWO | TUESDAY, MARCH 204:00-5:30PM Session 9


Mixology: Headaches and Cures for Medical Information

Challenges

TRACK 2A

Scientific Communication Strategy

TRACK 2B

Secrets of the Editorial Office

TRACK 3

Are You Prepared to Ride the Tsunami of Change in Medicine or

Will You Drown?

Session Chair Maureen Feeney, MBA, PharmD, RPh Head Global Medical Information Shire Pharmaceuticals

Medical Information and Communication roles continue to evolve. At the same time, companies face challenges in determining the appropriate level of service in the face of constrained resources. This session will explore the everyday challenges facing medical communication and information professionals and provide practical examples to current challenges.


• Develop solutions to manage support across the product lifecycle

• Develop impactful solution and tips to improve customer service

• Apply practical examples to enable more efficient use of existing resources

When to Cut the Cord? Managing Medical Information Support Across Product Lifecycles

Kelly Pincus, PharmD Director, Medical Information Cardiovascular, Metabolic, Immunology, Critical Care Handling Safety Inquires GlaxoSmithKline

Tackling Tough Questions – Answering Adverse Event Questions

Hiren Patel, PharmD Director, Medical Information Sunovion Pharmaceuticals, Inc.

Road Trip! Planning for a Successful Congress

Tanya Basu Director, Medical Communications Shire Pharmaceuticals

Session Chair David Clemow, PhD Advisor, Scientific Communications Information Strategy Eli Lilly and Company

This session will provide insights and best practices for creating and organizing consistent messaging across regulatory submission and publication documents, with a focus on mapping clinical trial data outputs to key messages and downstream disclosure documents. The role of scientific communications (medical writing) in medical key message development, knowledge management, and dissemination will be discussed, with suggestions for process integration with other medical functions to aid with synergy.


• Apply and map clinical trial data outputs and related key messages from target profile through regulatory submission documents and publication disclosures

• Define the role of scientific communications in medical key message development, knowledge management, and dissemination related to cross-functional partners

• Explain the involvement of the medical writer role in scientific communications strategy

Submission Communication Strategy Document to Drive Consistent Messaging in CTD Dossiers

David Brown, MA Therapy Area Leader, Medical Communications Science AstraZeneca

Medical and Scientific Key Message Development, Knowledge Management, and Dissemination

David Clemow, PhD Advisor, Scientific Communications Information Strategy Eli Lilly and Company

Medical Writing Leadership in Scientific Communications Strategy

Michael Bourque, MS Associate Director, Principal Regulatory Writer Synchrogenix, a Certara Company

Session Chair Ann Winter-Vann, PhD Senior Medical Writer and Consultant Whitsell Innovations, Inc.

Why do editorial offices insist on things being that way and why do different journals ask for things in quite different styles? How can you make your manuscript better? How can you ensure your article will be reviewed? The editorial office is actually there to help authors (though it might not always seem like it!). Join us and find out what happens after your manuscript is submitted to a research journal.


• Describe the process for review of a manuscript

• Evaluate the editor’s role in the review process

• Assess the need to adhere to submission requirements

Jan Higgins, PhD Managing Editor, Genetics in Medicine American College of Medical Genetics and Genomics

Elizabeth Blalock, MA Managing Editor, Journal of Investigative Dermatology Society for Investigative Dermatology

Session Chair Robin Winter-Sperry, MD Head, Global Field Based Medical Excellence & Insights Sanofi Genzyme

Be disruptive, be provocative but be educated. This session will focus on the changes occurring in medicine from multiple perspectives. Leaders from medical media and digital medicine will provide a highly interactive and engaging session on ways to adapt field based medical teams to meet changing KOL needs.


• Recognize areas that are emerging in the field of digital medicine and trends in the industry

• Identify methods by which MSLs and their Medical Affairs colleagues are evolving and adapting to the changing medical environment both locally and globally

Kirk Shepard, MD Senior Vice President, Head of Global Medical Affairs Oncology Eisai, Inc.

Taren Grom Editor PharmaVoice

Jonathan Weiner, PharmD, MBA Director of Innovation in Scientific Exchange Sanofi

5:30-6:30PM Resident and Fellow Poster Reception and Networking7:00-9:00PM Dinner on the Town

Traveling on your own or looking to connect with fellow attendees? Visit the DIA Registration Desk to link up for dinner! Sign-up sheets will be provided for various local restaurants. Cost of dinner is the responsibility of the individual attendee.





DAY THREE | WEDNESDAY, MARCH 216:00-7:00AM DIAfit: PIYO Mix (Pilates/Yoga)

Instructor Tracy Meats Certified Personal Trainer

Enjoy a class that will awaken your core muscles and elongate your posture with fundamental Pilates exercise and basic yoga poses.

7:00AM-2:45PM Registration7:00-8:00AM Networking Breakfast in the Exhibit Hall8:00-9:30AM Session 10


Podium Pearls

TRACK 2

Managing Up, Down, and Across: Effective Medical Writing Management Strategies

and Business Practices

TRACK 3

The Strategic MSL – Applying Business Acumen

Session Chair Poonam Bordoloi, PharmD I&I Lead, Research and Early Pipeline Medical Communications Celgene Corporation

Medical communications professionals will be presenting their successes, challenges, and “pearls of wisdom” on various topics through podium presentations.

At the conclusion of this session, participants should be able to:• Discuss and share best practices,

experiences, and innovative processes for medical communications topics related to Social media and new tools for engagement, collaborating across medical affairs, contact center and actionable insights, EU collaborative pharma portal(s), proactive HCP Whatsapp Broadcast initiative launched outside the US, and the use of readability formulas within medical writing for clinical trial summaries

Medical Information (MI) Social Media Activities in Canada: Impact of Post Type on Engagement RateRania Gaspo, PhD Director, Global Therapy Area Lead, External Medical Communications Pfizer, Inc., Canada

How Successful Medical Affairs Teams Make the Most of Their Real-World Data to Benefit PatientsIsabelle Widmer, MD Medical Affairs Consultant Elytra GmbH

Analysis of Medical Information Contact Center Data: Business Insights and OpportunitiesNicholas Liu, PharmD Medical Information Associate Lundbeck

A MILEstone - Creating the European Industry Association for Medical InformationAurelio Benassini, MD Executive Director Global Medical Information Merck & Co.

MI-ND Medical Information-News Delivery: Providing Customers with Medical Information “Proactively” by Using WhatsBroadcastMarie-Luise Helmich, PhD Head of Europe Medical Information Sanofi, Germany

Clinical Trial Summaries: Readability to Effectively Inform PatientsAutumn Watson Biomedical Writing Student University of The Sciences In Philadelphia

Session Co-Chairs Michael Church, MA Senior Director, Medical Writing Syneos Health

Ann Winter-Vann, PhD Senior Medical Writer and Consultant Whitsell Innovations, Inc.

All medical writing managers face a common set of problems. Forecasting work for staff accurately can be challenging as timelines shift and clinical plans change; teammates may struggle to work well together; experience levels across both internal staff and external contractors may vary greatly; and developing junior-level staff may become an afterthought in the midst of the chaos of just getting work done. This session will tackle the issues of running an effective medical writing business through a panel discussion with leaders and managers from a variety of backgrounds and companies and will provide a forum for associates and managers in medical writing to ask questions and exchange information to improve business practices.

At the conclusion of this session, participants should be able to:• Develop effective resourcing strategies

for medical writing projects

• Discuss the complications of forecasting medical writing

• Operate more effectively with direct reports, peers, contract staff, and management

• Implement peer-mentoring strategies to develop staff

• Recognize risks within a medical writing business and develop mitigation strategies

Cynthia Hooper, MA Advisor, Biometrics Business Management and Advanced Analytics Eli Lilly and Company

Carri Taylor, MBA Associate Director, Medical Writing inVentive Health

Holly Zoog, PhD, ELS Executive Director, Medical Writing Ultragenyx Pharmaceuticals, Inc.

Matthew Robillard, MBA Senior Director, Regulatory Strategic Writing AbbVie, Inc.

Session Co-Chairs Kathleen Guindon, MS, PhD, RN Director, Clinical Science Liaison Puma Biotechnology

Rebecca Vermeulen, RPh Head, Customer Strategy Global Medical Affairs Hoffmann-La Roche, Ltd.

The ability to execute in customer-facing roles is changing. Business acumen is evolving into a core competency. Business acumen involves a keenness and quickness in understanding and dealing with a business situation. As a strategic skill, business acumen helps MSLs to manage their customers’ needs in alignment with organization goals. Success requires relationship development with key people in other organizational departments, and understanding their challenges. This leads to understanding their product and disease space more comprehensively. The end result is sound, strategic decision-making with all stakeholders in mind.

At the conclusion of this session, participants should be able to:• Define business acumen and describe the

importance of applying it in practice

• Utilize strategies to develop business acumen and support medical strategy

• Recognize what good business acumen looks like when applied in the field, and learn strategies for measuring success

Kathleen Guindon, MS, PhD, RN Director, Clinical Science Liaison Puma Biotechnology


9:30-10:30AM Refreshments and Networking Break in the Exhibit Hall - View Professional Posters





10:30AM-12:00PM Session 11Breakout Sessions

TRACK 1

Global Warming: Conserve Energy and Unify Partners

TRACK 2A

Understanding Patient-Reported Outcomes (PROs) in Clinical Trials:

The Value of Patient Experience

TRACK 2B

Personalized Medicine: Gene Therapy

TRACK 3

MSL Training – All Things Considered

Session Chair Anne Arvizu, PharmD, FASCP, PCC CEO and Medical Affairs Advisor RxER Communications

A fresh, tactical, and strategic approach to globalizing your MI Team. From the start up biotech prior to launch, to the global giant going through another re-org and acquiring new therapy areas, or companies. Change is always a factor to juggle in the global world. In the past, globalization sessions have focused on large pharma breakthroughs leaving many companies saying, “well, I’d like to do that in five years” or “that’s the goal” if I could get the budget. With the influx of small biotech companies and mid-sized pharma companies, together making up the majority of the industry and the new face of medical information, this year’s session focuses on practical takeaways for making a shift and gaining the right partnership and advocacy, no matter the size of the organization.

At the conclusion of this session, participants should be able to:• Identify practical approaches

to enable globalization process within an MI team

• Work with partners and stakeholders to rally and ratify your cause

• Select regulatory and compliance tactics to apply to globalizing an MI team

Success at the Core: A Team Approach for Launching Global Medical InformationHeather Sun, PharmD Director, Global Medical Information Alnylam Pharmaceuticals, Inc.

Don’t Globe it Alone: Expanding Awareness, and Country Capabilities in MITim Fish, DNP, MBA, RN, CENP Director, Global Medical Information Sarepta Therapeutics, Inc.

Making Contact: An Instant Globalization FootprintMichele Simon Director of Operations PPD

Session Chair Darryl L’Heureux, MsC, PhD, Mpharm Medical Writing Manager Bristol-Myers Squibb

This session will provide an introduction to PRO assessment, its role in the context of clinical trials, and emerging issues given evolving regulatory and payer landscapes.

At the conclusion of this session, participants should be able to:• Differentiate PROs from

other clinical outcomes and discuss the importance of their assessment

• Identify relevant considerations for collecting and evaluating PRO data

• Understand current issues regarding uses of PRO data for regulatory and payer applications

An Introduction to PRO AssessmentGregory Maglinte, PhD, PharmD, MPH WWHEOR Immuno-Oncology Lead Bristol-Myers Squibb

Current Issues in the Application and Interpretation of PRO DataAri Gnanasakthy, MBA, MSc Principal Scientist, Patient-Centered Outcomes Assessment RTI Health Solutions

Session Chair Eileen Girten, MS Principal Medical Writer PRA Health Sciences

You will leave this session with a basic understanding of what gene therapy is, how gene therapy works, and the challenges associated with education and awareness in the gene therapy space.

At the conclusion of this session, participants should be able to:• Differentiate between basic

types of gene therapy

• Explain how gene therapy works using simple terms

• Describe the key challenges associated with educating audiences about gene therapy

• Identify key insights regarding the straightforward communication of complex science

AAV Gene Therapies for Rare DiseaseKendra Bolt, PhD, CNIM Manager of Scientific Communications and Medical Writing Audentes Therapeutics

Session Chair Craig Klinger, RPh Consultant Field Medical Shared Services – Trainer Eli Lilly and Company


During this session we will discuss the challenges of centralized versus decentralized training in a global environment and how you manage content across regions. We will address technology and methods of sharing training to meet educational needs of MSLs across the globe. The session is being developed to consist of short introductory presentations to concepts and then a panel discussion with your participation.

At the conclusion of this session, participants should be able to:• Define the needs to

appropriately train an adult-based learner to prepare for a MSL role

• Describe centralized verus decentralized MSL on-boarding and training

• Identify technology which can facilitate training in a virtual setting

• Assemble a learning plan to facilitate on-boarding and continue the education of MSLs

Craig Klinger, RPh Consultant Field Medical Shared Services – Trainer Eli Lilly and Company

Harry Varav, PharmD Director Global Learning and Performance R&D Amgen, Inc.

Randy Miller, PharmD, RPh National Director, Medical Science Liaisons Alnylam Pharmaceuticals

DAY THREE | WEDNESDAY, MARCH 21

12:00-1:30PM Networking Luncheon and Exhibits - View Professional Posters

1:30-2:45PM To Thine Own Self be True: How Understanding Who You Are and What You Want Will Help You Build and Market Your BrandWe will show you how understanding your personality will help you make the most of your unique combination of talents to help you achieve career happiness. In our fun, dynamic, and interactive session, short presentations on personality types, presenting yourself, and networking activities, will be interspersed with breakout activities so you can practice and network with other conference goers. You will learn how to effectively communicate your professional background, understand the benefits of building a consistent brand, and discuss strategies for effective networking and the do’s and don’t of using social media.

Arlene Kray, PhD, PharmD Associate Director, Medical Writing PRA Health Sciences

Isabelle Widmer, MD Medical Affairs Consultant elytra GmbH, Switzerland


At the conclusion of the short course, participants should be able to:• Implement best practices for networking without fear/apprehension

• Understand the value of a consistent personal brand and how to develop one

• Utilize social media to effectively communicate ones’ personal brand

1:30-3:30PM Career Fair!

3:30PM Conference Adjourns





DIAglobal.org/DIA2018




http://DIAglobal.org/DIA2018

medical affairs and scientific communications forum · track 1: medical communications track 2:...

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